MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA; BTT

Model Number OPT944

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2022

Event Type  Injury  

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during use on a patient.The healthcare facility reported that the patient coded and was transferred to the intensive care unit.No further patient consequences were reported.Further information has been requested regarding the reported event.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested further information regarding the reported event as well as the complaint device to be returned for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in texas reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during use on a patient.The healthcare facility reported that the patient coded and was transferred to the intensive care unit.No further patient consequences were reported.Further information about the reported incident including the sequence of events and the patient's condition was requested from the healthcare facility, however the healthcare facility did not provide any of the requested information despite several attempts requesting this.

Manufacturer Narrative

(b)(4).Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.Nhf therapy and the airvo 2 device are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Method: several attempts to request further information from the healthcare facility were made, however no response was provided by the healthcare facility.The opt944 optiflow + adult nasal cannula was received at f&p new zealand for evaluation, where it was visually inspected.An investigation was carried out by f&p which was based on the initial information provided by the healthcare facility, our evaluation of the returned device, and our knowledge of the product.Results: the healthcare facility reported that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during use, the patient coded and was transferred to the intensive care unit.Further information about the reported incident including the sequence of events and the patient's condition was requested but was not provided.Visual inspection of the returned cannula revealed that the tubing was damaged and detached from the 3-way connector.Conclusion: we are unable to determine the cause of the reported event.However, based on our knowledge of the product and our observation that parts of the tubing were damaged, the reported event was likely caused by the cannula being subjected to excessive force.From the information provided by the healthcare facility, it cannot be established if there is any causal relationship between the subject device and the patient incident.Manufacturing controls for the opt944 optiflow + adult nasal cannula include inspections during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The subject opt944 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the headstrap clip and the tubing clip are appropriately attached.The user instructions also warn: - "ensure head strap clip is attached, to prevent cannula from being pulled out of the nares." - "cannula can become unattached if not used with the head strap clip." - "attach tubing clip to clothing/bedding to prevent cannula from pulling off face." - "do not crush or stretch tube, to prevent loss of therapy." - "failure to use the set-up described above can compromise performance and affect patient safety." - "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.".

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 14178329
• MDR Text Key: 294606592
• Report Number: 9611451-2022-00367
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other